Phase II Trial of Pulsed Taxol With Concurrent Thoracic Radiotherapy, & Adjuvant Chemo in Stage III NSCLC

• Status: Terminated
• Trial end date: 2017-08-22
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II study to evaluate the toxicity and overall survival of pulsed paclitaxel with concurrent thoracic radiotherapy, and adjuvant gemcitabine and carboplatin in stage IIIA and IIIB non-small cell lung cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leo W. Jenkins Cancer Center
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

1. Patients must have: IIIA or IIIB non-small cell lung cancer by radiographic or surgical staging, excluding: superior sulcus tumors, tumors with associated atelectasis or obstructive pneumonitis of the entire lung, and tumors with a malignant pleural effusion.

2. Patients will be included in the study based on the following criteria:

• Patients must be older than 18 years old.

• Patients must have a Zubrod performance status of 0 to 2

• Patients with adequate bone marrow function

• Patients with adequate renal function

• Patients with adequate hepatic function

• Patients of childbearing potential must have a negative serum pregnancy test and use an effective form of contraception.

• Patients who are suitable for treatment with radical intent using concurrent chemotherapy and radiation.

• Patients who have signed an approved informed consent and authorization permitting release of personal health information.

Exclusion Criteria:

1. Disease-Specific Exclusions

• Superior sulcus tumors

• Atelectasis or obstructive pneumonitis of the entire lung

• Malignant pleural effusion

2. General Medical Exclusions

• Surgical candidates

• Patients who are pregnant at the time of diagnosis

• Serious concomitant systemic disorders incompatible with the study

• Inability to comply with study and/or follow-up procedures

• Life expectancy of less than 12 weeks

• Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study

• Patients with septicemia or severe infection.

• Patients who have circumstances that will not permit completion of this study or the required follow-up

• Patients with any contraindication to gemcitabine, carboplatin, or paclitaxel